Field of the Invention
The present invention relates to a cartridge set for manufacturing a syringe which stores cartridges to be used when manufacturing a dual-chamber type combined container-syringe and a method for manufacturing a dual-chamber type combined container-syringe using the cartridge set for manufacturing a syringe.
Description of Related Art
Combined container-syringes, which are designed so that an injection preparation is previously filled into the inside of a syringe and an injection can be given immediately to a patient by taking out the syringe from a packing at the time of use, have been widely adopted by medical institutions in all the countries of the world in terms of convenience, safety, and to prevent misuse of an injection drug.
In recent years, so-called dual-chamber type combined container-syringe (for example, refer to Japanese Patent No. 1759157) in which a front chamber is filled with a powder preparation, and a rear chamber is filled with a solvent (suspension) have been in widespread use. As a type that is most widely adopted among them, a syringe that is described in Japanese Patent No. 1759157 is well known.
In this dual-chamber type combined container-syringe, a front assembly made from plastic is fitted to a tip portion of a glass cartridge, and a finger grip is fitted to a rear end portion of the cartridge. A bypass portion that allows the front chamber and the rear chamber to communicate with each other is molded in an intermediate portion of the cylindrical cartridge. The powder preparation filled into the inside of the front chamber is sealed air-tight and liquid-tight by a front stopper and a middle stopper, and the solvent filled into the inside of the rear chamber is sealed air-tight and liquid-tight by the middle stopper and an end stopper. During injection, the end stopper is advanced by pushing a plunger rod screwed to an internal thread provided in a rear portion of the end stopper, and in conjunction with this, the middle stopper inserted in the front end of the rear chamber moves forward along with the solvent within the rear chamber.
Then, when the middle stopper reaches a bypass portion molded on the cartridge, the solvent moves to the front chamber through a gap between the outer peripheral surface of the middle stopper and the bypass portion. In this case, the middle stopper stops at that position until the front face of the end stopper comes into contact with the rear face of the middle stopper. Next, when all of the solvent in the rear chamber has flowed into the front chamber, and the tip of the middle stopper has passed through the bypass portion, the press of the plunger rod is stopped, and an injection drug is adjusted by adequately shaking the overall syringe to sufficiently dissolve (suspend) the powder preparation with the solvent. Thereafter, the plunger rod is pushed in again, and the front stopper that has stopped inside at the tip of the cartridge is made to enter a bypass chamber inside a hub lure lock. Thereby, the seal within the syringe is released by several longitudinal grooves provided in the inner wall of the bypass chamber. Thereafter, after bubbles remaining within the front chamber are discharged, an injection drug is guided to an injection needle through a nozzle head of the hub lure lock in the front assembly utilizing the longitudinal grooves, and the injection drug is administered to a patient.
Here, the dual-chamber type combined container-syringes are delivered to a pharmaceutical company in a state where respective members thereof are not yet assembled. These members are sterilized by the pharmaceutical company, and are sent to and assembled in the following steps, respectively.
That is, after the members are sterilized, the cartridge is put on a filling machine in an aseptic area, and insertion of the sterilized end stopper, filling of the solvent, and insertion of the middle stopper into the cartridge are performed. Thereafter, if necessary, sterilization of the filled solvent by steam sterilization is performed and drying is performed. Then, the front chamber is filled with the powder preparation by a separate filling machine, and the front stopper is inserted into and sealed at the tip portion of the cartridge. Otherwise, a liquid preparation is filled instead of the powder preparation, and the cartridge is put into a lyophilizer to lyophilize the liquid preparation. Then, the front stopper is inserted into and sealed at the tip portion of the cartridge within the lyophilizer. Then, the front assembly is fitted and assembled to the front end of the glass cartridge that has undergone the filling step, and the finger grip is fitted and assembled to the rear end of the cartridge.
Here, in the case of single-chamber type combined container-syringes in which only one kind of injection drug is sealed, empty syringes that are not filled with the injection drug are assembled by a syringe maker and delivered to a pharmaceutical company are common. That is, generally, syringes are delivered to a pharmaceutical company in a state where empty single-chamber type combined container-syringes in which the front assembly and the finger grip are fitted to both ends of the cartridge in advance are regularly aligned in a nest (supporting plate) made of plastics, these syringes are stored in a tub (container), and a lid member, such as nonwoven fabric, is heat-sealed to the top face of the tub.
In addition, the empty single-chamber type combined container-syringes are supported by the nest as the finger grips are caught in through-holes of the nest in a state where the cartridges are inserted through the through-holes of the nest.
In a manufacturing process of a single-chamber type combined container-syringe in a current pharmaceutical company, a method of putting empty single-chamber type combined container-syringes which have been packed by the nest and the tub in a dedicated medical fluid filling and sealing equipment, inserting the front stoppers at high speed, filling an injection drug, and inserting the end stoppers to seal the syringes is widely adopted. Such a method is used for filling, assembling, packing, and the like of various vaccines, and greatly contributes to the adoption and the spreading of the single-chamber type combined container-syringes.
Here, in the case of the dual-chamber type combined container-syringe, the filling of the solvent, the steam sterilization of the solvent after the filling, the aseptic filling of the powder preparation, the adjustment of the filling amount of the solvent or the powder preparation, and the like, are more difficult than the single-chamber type combined container-syringe. Moreover, in the case of the dual-chamber type combined container-syringe, manufacturing steps are complicated and very difficult, such as being required to lyophilize a preparation, and insert and seal the stoppers within the lyophilizer.
When such a difficult steps are performed on a cartridge, constant precision cannot be ensured in a state where the front assembly or the finger grip is fitted to the cartridge. Particularly, if the steam sterilization or the lyophilizing step is performed in a state where the front assembly or the finger grip is fitted, the front assembly or the finger grip may expand or contract, and the precision of assembling, the strength of the syringe or the like may be reduced and deteriorated. Therefore, this is not preferable.
Thus, in the process of manufacturing a dual-chamber type combined container-syringe, it is preferable to perform, on a cartridge as a single body, the step of inserting the various stoppers, the steps of filling and sealing the solvent, the powder preparation, a lyophilizing preparation, or the like, before and after the insertion of the various stoppers. However, in a case where it is intended to support only the cartridge on the supporting plate, since the finger grip is not fitted to the cartridge, the cartridge cannot be supported on the supporting plate with a backlash therebetween. Accordingly, there is a possibility in that fine adjustment, such as position adjustment when the various stoppers or the like are inserted into the cartridge is difficult, and various steps cannot be smoothly performed.
The invention has been made in view of the above circumstances, and an object thereof is to provide a cartridge set for manufacturing a syringe capable of easily and smoothly manufacturing a dual-chamber type combined container-syringe, and a method for manufacturing a dual-chamber type combined container-syringe using the cartridge set for manufacturing a syringe.